Janssen Biotech announced that the Food and Drug Administration (FDA) has approved Darzalex (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received ≥2 prior therapies including lenalidomide and a proteasome inhibitor (PI).
The FDA approval was based on data from the Phase 1b EQUULEUS study (n=103) that demonstrated an overall response rate (ORR) of 59.2% (95% CI: 49.1, 68.8) with very good partial response (VGPR) seen in 28.2% of patients who were treated with Darzalex 16mg/kg in combination with pomalidomide and low-dose dexamethasone.
Complete response (CR) was seen in 5.8% of patients, stringent CR in 7.8% of patients, and partial response in 17.5% of patients. The median time to response was one month with a median duration of response of 13.6 months.
The safety data of the Darzalex combination therapy was similar to the established profile of Darzalex monotherapy and pomalidomide + dexamethasone, respectively. In the study, the most common adverse reactions were infusion reactions, diarrhea, constipation, nausea, vomiting, fatigue, pyrexia, upper respiratory tract infection, and others.
Darzalex, a CD38-directed antibody, was initially approved as a monotherapy for patients with multiple myeloma who had received ≥3 prior lines of therapy, including a PI and an immunomodulatory agent. It was later approved for use with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who received ≥1 prior therapy.
Darzalex is supplied as 100mg/5mL and 400mg/20mL strength solutions for intravenous (IV) infusion after dilution.
For more information call (800) 526-7736 or visit Darzalex.com.